FDA Approves Incruse Ellipta for COPD

GlaxoSmithKline (GSK) announced that it has received approval from the FDA for Incruse(™) Ellipta® (umeclidinium) as a long-term once-daily treatment for chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.  Incruse Ellipta is GSK's first mono therapy in the anticholinergic class.  The drug had already been approved in Canada and Europe.  The approved dose is 62.5 ug to be delivered through the Ellipta® inhaler.  GSK warns that Incruse Ellipta should not be used in patients with hypersensitivity to milk proteins, asthma or with severe cardiovascular disorders and advised against using the drug for the treatment of acute episodes of bronchospasm.  In addition, the drug  should be used with caution in patients with narrow-angle glaucoma or urinary retention.  The most common adverse reactions are nasopharyngitis, upper respiratory tract infection, cough, and arthralgia.

[1] GSK receives approval for Incruse(™) Ellipta® (umeclidinium) in the US for the treatment of COPD